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Acessa Procedure - Minimally Invasive Treatment for Uterine Fibroids


 

What is the Acessa procedure?

The Acessa procedure is a minimally invasive, outpatient treatment that involves two small abdominal incisions. It uses controlled radiofrequency energy, heat, to cause coagulative necrosis of the fibroid tissue. The treated tissue softens and shrinks over time, allowing fibroid symptoms to resolve with no suturing of the uterine tissue. Unlike many alternative interventions, the Acessa procedure optimizes imaging of the uterus by simultaneously displaying the laparoscopic camera view and the ultrasound view in real-time, so physicians can identify and treat nearly all locations of fibroids, including those outside the uterine cavity and within uterine walls. Women typically experience minimal discomfort after the procedure, quick return to normal activities in 4-5 days, and long term satisfaction and relief.

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Who is this procedure for?

This procedure is for pre-menopausal women (typically younger than 55 years old) who are tired of living with the ongoing pain and discomfort of fibroid symptoms and are looking for a minimally invasive option that allows them to keep their uterus and return to daily life quickly after the procedure.

Can Acessa treat large fibroids? How many fibroids can Acessa treat?

Size and number of fibroids are important factors in what procedure is right for you. That’s why physicians order an MRI or ultrasound prior to determining if you are a candidate for the procedure. A physician can treat any number of fibroids present1. The number of fibroids that a physician is able to treat in a single procedure may vary. The ability to treat more fibroids thanks to laparoscopic ultrasound imaging can be an advantage of Acessa compared to myomectomy2,3 The safety and effectiveness of the Acessa procedure has not been evaluated in women with uterine size greater than 14 weeks (which roughly equates to a single ~9 cm diameter fibroid)

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What types of fibroids can Acessa treat?

Acessa can be used to treat almost all types of symptomatic uterine fibroids, including subserosal,intramural, transmural, and submucosal.

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How does Acessa compare to other treatment options?

Vs. Hysterectomy – Acessa keeps your uterus and has a quicker recover and less scars3 however, hysterectomy is a definitive treatment, so after recovery, there is no chance fibroid symptoms will return

Vs. Myomectomy – Acessa is typically considered less invasive than a myomectomy, even a robotic myomectomy, because there is less blood loss during the procedure, less scars and no cutting and suturing of uterine tissue.Also, for patients with multiple, small fibroids, physicians often note that Acessa can be a more accurate procedure because it utilizes an ultrasound to find and target more fibroids whereas most myomectomies the surgeon is only using his or her eyes. However, because myomectomies remove the fibroid right away, patients with larger fibroids may experience quicker relief from bulking than with Acessa, which can take longer to shrink fibroids.

Vs. Hysteroscopic options (GEA, hysteroscopic myomectomy, transcervial RFA) – Acessa may be considered a more comprehensive treatment option for fibroids because the procedure is performed laparoscopically, through the stomach, vs. through the cervix, which allows surgeons to target fibroids all around the uterus, however, hysteroscopic options can be quicker and comprehensive for patients which fibroids that are closer to or in the uterine cavity.

If the fibroids are not physically removed, how does Acessa work?

Studies show that fibroids do not have to be completely removed to resolve symptoms. Treating the fibroid cells so they shrink and stop putting pressure on the uterus may help to resolve symptoms. The data in the IDE clinical study showed even a 45.1% average shrinkage in fibroid volume can result in significant improvement in heavy periods, pelvic pain and bulk.

As a reminder, Acessa is a treatment for benign (non-cancerous) symptomatic fibroids. If patients are at risk for cancer or malignancy, Acessa is not the appropriate treatment.

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What are the results of the Acessa procedure?

  • Acessa addresses nearly all symptoms such as excessive bleeding, prolonged periods, urinary frequency, painful sex, stomach, lower-back and pelvic pain. Individual results vary based.
  • In clinical studies, there was an average shrinkage of 45% in fibroid size post-procedure. This number is contingent on where the fibroid is located and the size.
  • Women typically see the most symptom improvement within 3 months of the procedure with continued improvement throughout the first year.
  • Studies have shown both clinically and statistically significant reduction in period blood loss.
  • BY THE NUMBERS:
  • 82% of women had lighter periods.
  • 94% patient satisfaction rate.
  • 11% of patients required additional reintervention after the Acessa procedure.

Is it covered by insurance?

Many insurance companies and Medicaid carriers cover the procedure. We understand that some patients have received incorrect information from insurance call centers. We suggest scheduling an appointment one of our Acessa trained physicians to discuss whether the procedure is appropriate for you. If Acessa is a match for your fibroid treatment, then your physician’s office will request insurance approval in advance by submitting a pre-authorization request.

Where can I learn more?

www.acessaprocedure.com

Disclaimer

Acessa Health does not make any recommendations, referrals, or endorsements regarding specific physicians with whom patients may seek treatment, nor does this site serve as a tool for verification of a specific surgeon’s credentials, qualifications, or abilities. Only a trained physician is qualified to recommend treatments and/or make diagnoses. You assume full responsibility for your communications and interactions made with any physician you choose to contact from the use of this website.

Risk Statement

The Acessa ProVu system is cleared by the FDA for the treatment of symptomatic uterine fibroids under laparoscopic ultrasound guidance.

The Acessa procedure is generally safe but complications may occur and can be serious. Risks and complications associated with the Acessa procedure include, but are not limited to: skin burns from the dispersion of radiofrequency energy, mild intra-operative bleeding, transient urinary retention or urinary tract infection, adhesion formation, post-procedural discomfort (cramping, pelvic pain), and transient amenorrhea, infection, injury to adjacent structures, vaginal bleeding and temporary anemia, blood loss requiring transfusion or hysterectomy, pneumothorax, wound dehiscence, deep vein thrombosis and pulmonary embolus, treatment failure, and complications related to laparoscopy and/or general anaesthesia including death.

Insufficient data exists on which to evaluate the safety and effectiveness of Acessa procedure in women who plan future pregnancy. Therefore, the Acessa procedure is not recommended for women who are planning future pregnancy. There is limited data regarding pregnancy following the Acessa procedure, if you become pregnant following the Acessa procedure, you should contact your doctor immediately. Please consult with your doctor to understand the risks and benefits of surgery and find out if Acessa may be right for you. Rx Only.

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